Saturday, January 26, 2019

Three Months Of New Studies

One way that I find new studies which are aimed at curing type-1 diabetes, is by searching the FDA's Clinical Trial Registry. (Luckily for me, this site even works during a partial government shutdown.) In this posting, I'm going to summarize all of the type-1 studies I found which were first registered from Oct-1 to Dec-31, 2018 and which either were recruiting patients, or had been.  (I'm specifically excluding studies which were registered, but which had not yet started recruiting.)

Out of the 41 studies which started during this time, only three (7%) were focused on curing T1D.  However, I'm summarizing all of them here, to give everyone a feel for all the types of type-1 diabetes research underway, and because some people might be interested in some of the non-cure research.

I divided these studies into 6 broad categories:

1. Treatment (16 Studies)
This section included psychological techniques to improve BG numbers, technology such as apps, training to recover low BG awareness, non-insulin drugs to treat or prevent lows, etc.

2. Technology (10 Studies)
These studies were mostly aimed at closed loops, but also other forms of technology, such as meters.  The most interesting (which I will not be covering) is a triple hormone artificial pancreas: researchers at McGill University are testing an artificial pancreas which doses Insulin, Pramlintide, and Glucagon.  They hope it will remove the need for carb counting.

3. Diet (Studies)
Two low carb studies, one on something about buckwheat, and I can't remember the fourth.

4. New Insulin (Studies)
I'm not particularly interested in new types of insulin, and most of these were standard "we hope it is a little better, and a little more expensive, than you get now" type insulin.  However, two of these studies were looking at a weekly use insulin.  Called "Insulin 287", it is a background insulin, similar to Lantus, Levemir, or Tresiba, but designed to be taken once a week.

5. Basic Science (1 Study)
Basic science studies are usually done on animals or in petri dishes, however there is one being started on people.  It is studying TMEM219 also called "TMEM219 death factor" and "Transmembrane Protein 219".  This protein is clearly involved in the death of beta cells, and is sensitive to insulin-related proteins.  There is hope that it is part of the process that kills beta cells to start type-1 diabetes, and therefore if we learn more about it, we can prevent type-1.

6. Cure Focused Research (Studies)
Finally, there were three studies which were focused on a cure.  I plan to blog on each one of these separately in the coming weeks, as they are all interesting and worth an individual blog:
MER3101 (an adjuvanated Insulin B Chain vaccine)
AG019 and Teplizumab (a mash-up of Proinsulin, IL-10, a monoclonal antibody, and bioengineering)
GABA (a dietary supplement)

Joshua Levy 
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Bigfoot Biomedical news, views, policies or opinions. In my day job, I work in software for Bigfoot Biomedical. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.


Oscar said...

Of the three cure-oriented studies you cite, the first, the MAS-1 adjuvenated insulin B-chain intervention, seems designed just to reduce the autoimmune aspect of diabetes, but since Faustman has long since shown that beta cells won't grow back just because the autoimmune attack on them is suspended, this study won't accomplish much without something to stimulate beta cell growth. Similarly, the second study, using AGO19 or AGO19 plus teplizumab to combat recent-onset type 1 diabetes in order to preserve as many beta cells as possible, would only help very new onset patients, as would an intervention with any other immunosuppressant or immuno-modulator, which have been tried since forever. Finally, the GABA study has probably already been performed but unknowingly, since GABA is a very popular supplement for mood elevation and pain relief, so among those using it there must have been many type 1 patients, yet no diabetes cures among them have been reported. But this is to be expected, since GABA only promotes the conversion of other cells to beta cells, which will only intensify the autoimmune attack by increasing the beta cell mass it targets, and probably just worsen the inflammation that type 1 diabetics already suffer, and this is causally implicated in the development of diabetic complications. GABA would have to be combined with some immunosuppressive intervention to show any benefit, performing the role of Faustman's INGAP polypeptide, and so the experiment probably won't show any results in the absence of immunosuppression. But given the unacceptable toxicity of immunosuppressives, increasing beta cell mass may not be part of a viable route to curing type 1 diabetes.

Traci W said...

Thank you for taking the time to share this updated information. I look forward to looking more into some of these. Inflammation and diabetes has been extremely interesting to me as of late due to some of the things my late-ex dealt with and possibly had.


What about Gaba + anti il 21? Have you considered this combination?

Oscar said...

GABA is a fairly interesting therapeutic strategy for curing type 1 diabetes, since GABA not only promotes the conversion of pancreatic alpha cells to beta cells, but it also partially suppresses the autoimmune attack on the beta cells, and additionally offers some protection against the toxicity of certain immunosuppressive drugs, such as tacrolimus. The problem is that it does all of these things only to a limited degree, so difficulties would still remain. The most challenging aspect of using GABA to regrow beta cells, apart from its needing supplementation by toxic immunosuppressive drugs, is the fact that GABA can triple or quadruple levels of human growth hormone in the body, which very powerfully promotes diabetic complications, especially diabetic retinopathy. So would it be a net benefit to increase beta cell mass at the expense of life-long immunosuppression and its associated toxicity, plus a constant promotion of diabetic complications by human growth hormone? Probably not.


Absolutely agree with all the facts. But anti il 21 is a new therapy, now tested in clinical trials, with low toxicity (if any) since it suppresses only one cytokine (il 21) mainly responsible for all autoimmune diseases, including diabetes T1. Also, Diamyd Medical is launching new vaccine next year. Stay positive!